February 7 2011, BUFFALO, NY — The nation’s first FDA-approved cancer treatment vaccine, Provenge (sipuleucel-T), is being offered for the first time in Western New York at Roswell Park Cancer Institute (RPCI). The vaccine is designed for men with advanced prostate cancer who have limited treatment options and who meet eligibility requirements.
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A four part interview with Hy Levitsky M.D., professor of oncology and tumor immunology at Johns Hopkins Medical School and co-inventor GVAX anti-cancer vaccine, is posted on Dendreon Investor Village website.
Interview conducted by rufustoehee, a dentist and Dendreon investor, published 4/22/2009.
By way of introduction, Dr Levitsky’s bio is posted alphabetically downpage among those of other speakers at Cancer Immunology & Immunotherapy 2008: From Discovery to Development to Drug.
EXCERPTS FROM INTERVIEW
Conversation with Dr. Levitsky Part 1
“. . . . how this impacts on the field of tumor immunology, I feel it will very much depend on the nature of the data they present, assuming for the sake of discussion, that this is an unequivocal and unambiguous win, then I think it will have a very significant impact. Number one, I think that unless there are aspects to this that have not been made public, I think the FDA would in this instance need to move it forward in the approval process and I think that how it ultimately gets integrated into clinical practice will be a fascinating thing to watch.
“. . . . It is important to acknowledge that tumor response is a surrogate endpoint. It is a surrogate endpoint for perhaps 2 other endpoints that might be more meaningful. One is overall survival which is the gold standard and the other perhaps is the quality of life. No one can argue that those two things have sort of the paramount importance where as to an objective 50% or greater reduction in the mean diameter of all measurable tumor masses is an interesting yard stick, but it is only a yard stick.”